FDA Approves Nivolumab for the Treatment of Classic Hodgkin Lymphoma

Friday, July 1, 2016

The FDA approved nivolumab for the treatment of classic Hodgkin lymphoma (cHL) for patients who have relapsed or progressed after autologous hematopoietic cell transplantation (AHCT) and post-transplantation brentuximab vedotin. The recommended dose of nivolumab is 3 mg/kg administered intravenously every two weeks until disease progression or unacceptable toxicity.

The approval was based on results from two single-arm, multi-center studies evaluating safety (n=263) and efficacy (n=95) in relapsed/refractory cHL patients treated with single-agent nivolumab. Patients had received a median five prior systematic regimens (range = 3-15 regimens) and received a median 17 doses of nivolumab (range = 3-48 doses).